A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04161976 |
Recruitment Status :
Completed
First Posted : November 13, 2019
Last Update Posted : August 5, 2020
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 1 | Drug: LY900027 Drug: Insulin Lispro | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy |
Actual Study Start Date : | December 27, 2019 |
Actual Primary Completion Date : | July 14, 2020 |
Actual Study Completion Date : | July 14, 2020 |

Arm | Intervention/treatment |
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Experimental: LY900027
LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
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Drug: LY900027
LY900027 administered to participants with T1DM using CSII. |
Active Comparator: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.
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Drug: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII.
Other Names:
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- Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) [ Time Frame: Day 1 through Day 10 in each dosing period ]PK: AUC after Bolus Administration Prior to a MMTT
- PK: Maximum Observed Insulin Lispro Concentration (Cmax) [ Time Frame: Day 1 through Day 10 in each dosing period ]PK: C PK: Cmax
- Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion [ Time Frame: Day 1 through Day 10 in each dosing period ]PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
- PD: Total Daily Insulin Dose [ Time Frame: Day 1 through Day 10 in each dosing period ]PD: Total Daily Insulin Dose
- Duration Until Catheter Failure [ Time Frame: Day -1 through Day 10 in each dosing period ]Duration Until Catheter Failure

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of T1DM for at least 1 year
- Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
- Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
- Participants should have a glycated hemoglobin of ≤9.0% at screening
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161976
Germany | |
Profil Institut für Stoffwechselforschung | |
Neuss, Nordrhein-Westfalen, Germany, 41460 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04161976 |
Other Study ID Numbers: |
17489 J2H-MC-IUAA ( Other Identifier: Eli Lilly and Company ) 2019-002318-37 ( EudraCT Number ) |
First Posted: | November 13, 2019 Key Record Dates |
Last Update Posted: | August 5, 2020 |
Last Verified: | August 1, 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |